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KMID : 1146320140020020114
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Journal of Health Technology Assessment
2014 Volume.2 No. 2 p.114 ~ p.123
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Comparison of Zotarolimus-Eluting Stent and Everolimus-Eluting Bioresorbable Vascular Scaffold in Patient with Coronary Artery Disease: A Systematic Review and Adjusted Indirect Comparison
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Park Hyung-Deuk
Yoo So-Jung
Jung Eun-Young
Lee Soo-Yeon
Yu Ji-Sun
Lee Sang-Soo
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Abstract
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Objectives: Recently bioresorbable coronary stent has emerged as new version of percutaneous coronary intervention (PCI) technology. The expected benefits of this new technology are the reduction of stent thrombosis and impairment of coronary vasomotion. However, the comparative outcomes between bioresorbable coronary stent and current drug-eluting stents (DESs) are not known. This study is aimed to compare the safety and effectiveness of emerging bioresorbable coronary stents - everolimus-eluting bioresorbable vascular scaffold (BVS) to the well accepted DES technology - zotarolimus- eluting stent (ZES) - through Systematic Review and Adjusted Indirect Comparison with everolimus eluting stents (EES) for coronary artery disease (CAD) treatments.
Methods: A metaanalysis of clinical studies in which patients were randomly assigned to ZES versus EES or BVS versus EES were performed, as well as an indirect comparison of ZES versus EES, with EES common comparator. The primary endpoint was target lesion revascularization (TLR), while the secondary endpoints were a target vessel revascularization (TVR), a death, and a major adverse cardiac event (MACE).
Results: Six clinical studies were identified with a total of 7512 patients. Treatments with ZES versus EES were not associated with significant reductions of the TLR [odds ratio (95% confidence interval)=1.13 (0.88, 1.47), p=0.34], TVR [1.05 (0.81, 1.37), p=0.72], death [0.89 (0.64, 1.25), p=0.51], MACE [1.02 (0.85, 1.23), p=0.79] and Stent Thrombosis (ST) [1.35 (0.91, 2.00), p=0.13] BVS versus EES therapy also were not associated with significant reductions of TLR [0.59 (0.14, 2.53), p=0.47], TVR [0.48 (0.11, 1.99), p=0.31], death [0.33 (0.01, 8.20), p=0.50] and MACE [0.41 (0.10, 1.63), p=0.21]. The adjusted indirect comparison found that there were no differences between ZES and BVS in the risk of TLR [1.92 (0.44, 8.31), p=0.61], TVR [2.19 (0.52, 9.14), p=0.29], death [2.70 (0.09, 78.53), p=0.75] and MACE [2.49 (0.61, 10.20), p=0.29].
Conclusion: In patients with CAD, BVS has similar safety and effectiveness as that of ZES. In the case of indirect comparison, ZES and BVS may have comparable results in their effectiveness and safety. Long-term and large-scale randomized studies are required to confirm the study results.
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KEYWORD
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Bioresorbable vascular scaffold, Zotarolimus, Everolimus, Drug eluting stent, Coronary artery disease
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